Decreasing Post-Operative Nausea and Vomiting in the Bariatric Surgical Patient

Nausea, Postoperative Clinical Trial

Official title:

Decreasing Post-Operative Nausea and Vomiting in the Bariatric Surgical Patient

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06110416
• Other study ID #: 058.NUR.2020.M
• Status: Recruiting
• Phase: N/A
• Start date: December 23, 2020
• Est. completion date: November 23, 2024

Study information

• Verified date: January 2024
• Source: Methodist Health System
• Contact: Colette Ngo Ndjom, MS
• Phone: 214-947-1280
• Email: ClinicalResearch[@]mhd.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

From the research and current studies, post-operative nausea and vomiting is a common complaint after bariatric surgery. Nausea relief inhalers could improve post-operative nausea and vomiting without the need for further medications, subsequently reducing the chance of side effects. This study could help improve patient satisfaction and increase the ability of the patient to ambulate after surgery with the use of a nausea relief inhaler.

Description:

Post-operative nausea and vomiting is a very common and uncomfortable issue that occurs after bariatric surgery. 65% of patients have post-operative nausea and vomiting. Compared to previously published results, this percentage was higher than patients undergoing ambulatory surgery. The most common start of post-operative nausea and vomiting was in the first six hours but continued to increase during the first 24 hours. Post-operative nausea and vomiting inhibits early mobilization for the patient affected. Even patients that received nausea and vomiting prophylaxis at the optimal amount had an 82% of occurrence of nausea and vomiting. Post-operative nausea and vomiting occurred in 59% of the population that received greater than optimal prophylaxis. Researchers speculate that the high incidence of nausea and vomiting occurs due to potential damage of the vagal nerve during the operation. The motility of the stomach and intestines is also affected by the surgery and narcotics that patients take after the operation. Halliday and colleagues concluded that other methods of nausea and vomiting prevention should be evaluated in this population.

Aromatherapy and essential oils are an alternative method to controlling post-operative nausea and vomiting after post-surgical intervention. Although it has not been frequently studied in bariatric patients, it has been studied post-operatively for other surgeries and for vomiting after chemotherapy. According to a systematic review in 2012, three studies regarding post-operative nausea and vomiting found reduction in symptoms after inhalation of essential oils. The studies also noted reduction in need for nausea medication, improved patient satisfaction, and reduction in cost. A review by Cochrane and colleagues showed no reliable evidence of the effectiveness of peppermint oil. Other studies found that either peppermint or ginger were effective in the reduction of post-operative nausea and vomiting. However the studies had relatively small sample sizes and were not usually randomized control trials.

From the research and current studies, post-operative nausea and vomiting is a common complaint after bariatric surgery. Nausea relief inhalers could improve post-operative nausea and vomiting without the need for further medications, subsequently reducing the chance of side effects. This study could help improve patient satisfaction and increase the ability of the patient to ambulate after surgery with the use of a nausea relief inhaler.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: November 23, 2024
• Est. primary completion date: November 23, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Age 18 to 65 years old

• Attend the pre-operative class

• Must be able to read English

• Admitted to B4 surgical acute unit

• Surgery after May 31st, 2020

Exclusion Criteria:

• BMI greater than 60

• Pre-operatively on nausea medication

• Allergy to spearmint, lemon, ginger, and/or cedarwood

• History of Asthma or chronic obstructive pulmonary disease(COPD)

• Patient intubated or sedated for the 24 hours after surgery

Related Conditions & MeSH terms

• Nausea
• Nausea, Postoperative
• Postoperative Nausea and Vomiting
• Vomiting
• Vomiting, Postoperative

Intervention

Other:
• nausea relief inhaler
Aromatherapy and essential oils are an alternative method to controlling post-operative nausea and vomiting after post-surgical intervention.

Locations

Country	Name	City	State
United States	Methodist Mansfield Medical Center	Mansfield	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Methodist Health System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Medication Administration Record	The amount of nausea and vomiting medication use will be determined by the medication administration record during chart review in the first 24 hours for each study patient.	"Up to 24 hours"
Secondary	Rhodes index	Indicators of decreased stress and increased contentment will be found by patient's answers to questions regarding distress from dry heaving and retching and nausea and vomiting.	"Up to 24 hours"
Secondary	Length of stay	Length of stay will be tracked via chart review (date of discharge minus date of admittance)	duration of hospital stay: date of discharge minus date of admittance)